Comparative Effectiveness of Routine Antiemetic Prophylaxis in Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery
研究概览
简要总结
The aim of this prospective randomized double-blind study is to compare the effectiveness of routine antiemetic prophylaxis for the prevention of intraoperative nausea and vomiting (IONV) in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia.
Nausea and vomiting are common complications during cesarean delivery performed under spinal anesthesia and may negatively affect maternal comfort and perioperative safety. The incidence of these symptoms may be particularly increased in emergency cesarean sections involving non-fasted (full-stomach) parturients. This study compares two commonly used antiemetic strategies, namely 5-hydroxytryptamine-3 (5-HT3) receptor antagonists and dopamine receptor antagonists, to determine their relative effectiveness in preventing IONV during surgery.
The findings are expected to contribute to optimization of antiemetic prophylaxis protocols, improvement of maternal comfort, and reduction of perioperative complications associated with nausea and vomiting during emergency cesarean delivery.
详细描述
This prospective, randomized, double-blind clinical trial is designed to evaluate the comparative effectiveness of routine antiemetic prophylaxis for preventing intraoperative nausea and vomiting in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia.
Eligible participants will be pregnant women with American Society of Anesthesiologists (ASA) physical status I-II who undergo emergency cesarean delivery under spinal anesthesia. Only non-fasted (full-stomach) parturients will be included.
Exclusion criteria include ASA physical status III or higher, preoperative anemia, massive intraoperative hemorrhage, requirement for additional intraoperative hypnotic agents, known gastrointestinal disease, psychiatric disorders or psychotropic medication use, and administration of antiemetic medication within 24 hours before surgery.
Participants will be randomized using a sealed-envelope allocation method before arrival in the operating room. Before transfer to the operating room, patients will receive the assigned study medication according to the randomization protocol. Both patients and the attending anesthesiologist responsible for outcome assessment will remain blinded to group allocation.
Participants will receive one of the following prophylactic antiemetic regimens:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women scheduled for emergency cesarean delivery under spinal anesthesia
- •Non-fasted (full-stomach) parturients
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Age ≥ 18 years
- •Singleton pregnancy
- •Ability to provide written informed consent
排除标准
- •ASA physical status III or higher
- •Refusal to participate
- •Elective cesarean delivery (non-emergency cases)
- •Preoperative antiemetic use within 24 hours before surgery
- •Known allergy or contraindication to study drugs (ondansetron or metoclopramide)
- •Pre-existing gastrointestinal disorders (e.g., severe GERD, gastroparesis, bowel obstruction)
- •Psychiatric illness or current use of psychotropic medications
- •Preoperative anemia (as defined by institutional threshold, e.g., Hb < 10 g/dL)
- •Intraoperative conversion to general anesthesia
- •Massive intraoperative hemorrhage (>1000-1500 mL or requiring transfusion, depending on your protocol definition)
- •Intraoperative administration of additional sedative or antiemetic agents outside study protocol
- •Multiple gestation pregnancies
研究组 & 干预措施
Dopamine Receptor Antagonist Group
Participants undergoing emergency cesarean delivery under spinal anesthesia will receive prophylactic administration of a dopamine receptor antagonist before surgery. Intraoperative and early postoperative nausea and vomiting will be assessed.
干预措施: metoclopramide (Drug)
5-HT3 Receptor Antagonist Group
Participants undergoing emergency cesarean delivery under spinal anesthesia will receive prophylactic administration of a 5-HT3 receptor antagonist before surgery. Intraoperative and early postoperative nausea and vomiting will be assessed.
干预措施: Ondansetron 4mg (Drug)
结局指标
主要结局
Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery
时间窗: Perioperative
Incidence of nausea, retching, or vomiting occurring during the immediate period following fetal delivery, assessed using the Bellville scoring system. From fetal delivery until uterine closure.
次要结局
- Incidence of Intraoperative Nausea and Vomiting Between Spinal Anesthesia and Fetal Delivery(Perioperative)
- Incidence of Intraoperative Nausea and Vomiting Immediately Before Fetal Delivery(Perioperative)
- Incidence of Intraoperative Nausea and Vomiting During Skin Closure(Perioperative)
- Postoperative Complications Related to Antiemetic Prophylaxis(Postoperative)
研究者
Tolga Karaçay
Medical Doctor
Sanliurfa Education and Research Hospital